PMA Clinical Information
In August 2000, the Company received FDA review and acceptance
for its 5-step (module) pre-market approval (PMA) submission
plan. The first data module of the plan was submitted and
accepted shortly thereafter. Modules 2 and 3 were submitted
in Q2 and Q3 and accepted by the FDA in Q4 2001. Module Four
was submitted and accepted in 2002. The Company is taking
action to complete the final module as quickly as possible
so that final submission to the FDA can be made, with the
expectation of obtaining FDA approval. Marketing efforts in
the United States will begin soon thereafter.
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Cancer Institute of New Jersey, New Brunswick, NJ
Columbia Presbyterian Medical Center, New York, NY
Comprehensive Breast Center of Coral Springs, Coral Springs,
FL
Massachusetts General Hospital, Boston, MA
European Institute of Oncology, Milan, Italy
Gustave Roussy Institute, Paris, France
Hospital San Carlos, Madrid, Spain
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